風(fēng)險(xiǎn)管理是確保無(wú)菌藥品產(chǎn)品質(zhì)量的關(guān)鍵因素之一。對(duì)無(wú)菌藥品生產(chǎn)、分析檢測(cè)等過(guò)程中的存在的風(fēng)險(xiǎn)因素進(jìn)行識(shí)別和分析，進(jìn)行風(fēng)險(xiǎn)等級(jí)的評(píng)估是進(jìn)行無(wú)菌藥品質(zhì)量風(fēng)險(xiǎn)管理的前提條件?？偨Y(jié)了無(wú)菌藥品生產(chǎn)過(guò)程的質(zhì)量風(fēng)險(xiǎn)因素、無(wú)菌藥品生產(chǎn)質(zhì)量風(fēng)險(xiǎn)評(píng)估和無(wú)菌藥品生產(chǎn)的質(zhì)量風(fēng)險(xiǎn)控制，以期無(wú)菌藥品生產(chǎn)企業(yè)能夠顯著提升質(zhì)量風(fēng)險(xiǎn)管理能力，進(jìn)而創(chuàng)建一個(gè)高效、安全且穩(wěn)定的無(wú)菌藥品生產(chǎn)環(huán)境，確保最終產(chǎn)品的質(zhì)量達(dá)到既定標(biāo)準(zhǔn)和規(guī)范。

Risk management is one of the key factors to ensure sterile drug product quality. Identifying and analyzing risk factors in the production, analysis, and testing process of sterile drugs, and conducting risk level assessments are prerequisites for quality risk management of sterile drugs. This article summarizes the quality risk factors in the production process of sterile drugs, the quality risk assessment of sterile drug production, and the quality risk control of sterile drug production, with the aim of significantly improving the quality risk management ability of sterile drug production enterprises, creating an efficient, safe, and stable sterile drug production environment, and ensuring that the final product quality meets established standards and specifications.

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